Elastically deformable surgical access device having telescoping guide tube

ABSTRACT

A surgical access device is disclosed that includes an access port having an elongated body with opposed proximal and distal end portions and defining a longitudinal axis, the body having a central lumen extending there through and having a resilient bulb portion formed between the proximal and distal end portions thereof, wherein the resilient bulb portion is adapted and configured to transition between a first condition in which the bulb portion has a first diameter and a first length and a second condition in which the bulb portion has a second diameter that is less than the first diameter and a second length that is greater than the first length, and wherein a telescoping guide tube assembly is disposed within the central lumen of the access port body for accommodating an elongated insertion device, wherein the guide tube assembly is adapted and configured to transition between a first length corresponding to the first condition of the bulb portion and a second length corresponding to the second condition of the bulb portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

The subject application is a continuation-in-part of U.S. applicationSer. No. 11/544,856, filed Oct. 6, 2006, the disclosure of which isherein incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to sealable surgical access devices, andmore particularly, to such devices that are capable of deforming to alow-profile configuration to facilitate percutaneous insertion, forexample, into the abdominal wall of a patient.

2. Description of Related Art

A variety of surgical access devices are known in the art for providingaccess to a surgical cavity during minimally invasive surgicalprocedures. Such devices typically include a rigid tubular element,which defines a channel or lumen therethrough. The tubular elementprovides an open channel through the abdominal wall and into a surgicalcavity, through which surgical instruments can pass. Typically, a sealis provided to inhibit insufflation gas from exiting to the surroundingenvironment while surgical instruments are removed from the lumen.

Such conventional devices generally have been considered satisfactoryfor their intended purpose. However, such devices are relatively costlyto manufacture, being made from relatively expensive materials, such aspolycarbonate plastic. Such devices also inhibit movement of surgicalinstruments, due to the long, rigid and narrow lumen defined therein. Asa result, a surgeon must tilt the entire rigid access device, in orderto manipulate his instruments. Further, such devices are not typicallyprovided with a facility for anchoring to the abdominal wall, andtherefore can be accidentally removed therefrom during a procedure.Although some solutions to the foregoing problems have been developed,devices remedying some of these problems have been relatively complexand expensive. Therefore, there remains a continued need in the art fora surgical access device that provides access to a surgical cavity,which is a reduced encumbrance on a surgical procedure. There alsoremains a need in the art for such a surgical access device that isinexpensive and easy to manufacture. The present invention provides asolution for these problems.

SUMMARY OF THE INVENTION

The purpose and advantages of the present invention will be set forth inand apparent from the description that follows. Additional advantages ofthe invention will be realized and attained by the devices and methodsparticularly pointed out in the written description and claims hereof,as well as from the appended drawings.

In accordance with one aspect of the invention, a surgical access devicehaving an access port is provided. The access port has an elongated bodywith opposed proximal and distal end portions, and defines alongitudinal axis. The body has a central lumen extending therethrough,which in-turn includes a resilient bulb portion formed between theproximal and distal end portions of the body. The resilient bulb portionis adapted and configured to transition between a first condition inwhich the bulb portion has a first diameter and a first length and asecond condition in which the bulb portion has a second diameter and asecond length; the second diameter is less than the first diameter, andthe second length is greater than the first length. In accordance withthis aspect, a first engagement means is arranged in the distal endportion of the body, for engagement with a distal end portion of aninsertion device, such as a trocar. The insertion device is adapted andconfigured to releasably engage the distal end portion of the accessport body so as to facilitate a transition from the first condition tothe second condition of the bulb portion of the access port body.

In accordance with another aspect of the invention, a surgical accessdevice having an access port and an elongated trocar is provided. Theaccess port has an elongated body with opposed proximal and distal endportions, and defines a longitudinal axis. The body has a central lumenextending therethrough, which in-turn includes a resilient bulb portionformed between the proximal and distal end portions of the body. Theresilient bulb portion is adapted and configured to transition between afirst condition in which the bulb portion has a first diameter and afirst length and a second condition in which the bulb portion has asecond diameter and a second length. The second diameter of the bulbportion is less than the first diameter, and the second length of thebulb portion is greater than the first length.

The elongated trocar is adapted to extend into the central lumen of theaccess port body and configured to releasably engage the distal endportion of the access port body so as to facilitate a transition fromthe first condition of the bulb portion of the access port body to thesecond condition of the bulb portion of the access port body.

In accordance with either of the foregoing embodiments the followingfeatures can be incorporated therewith, as desired. The bulb portion canhave, for example, a generally spherical, generally ovoid, or othershape configuration in the first condition. The bulb portion of theaccess port body can be formed at least in part from an elastomericmaterial, such as silicone rubber. The bulb portion can have an outersurface with a substantially convex arcuate contour. The proximal endportion of the access port body can have a substantially constant outerdiameter. Further, the bulb portion in the first condition can includean expanded diameter, or can be substantially straight. Additionally oralternatively, the bulb portion can include one or more circumferentiallongitudinally spaced ribs or longitudinal circumferentially-spacedribs.

An insert sleeve can be disposed within the distal end portion of theaccess port body for engaging a distal end portion of the trocar and canbe arranged at the distal end of the access port body, forming a tipthereof. Such insert sleeve can be formed from a material having agreater rigidity than the access port body, and can be, for example,Nylon. The insert sleeve can include a plurality of proximally extendingexpandable guide fingers for lining an inner surface of the bulb portionto accommodate or facilitate insertion of the trocar. Additionally, ifdesired, an elongated guide tube can be provided, which extends throughthe proximal portion of the access port body and at least partially intothe bulb portion of the access port body.

Further, if desired, a substantially rigid generally planar flangeportion can be associated with the proximal end portion of the accessport body, and can define an access port communicating with the lumen ofthe access port body. Such access port can have a conically taperinglead-in surface. If provided, the insertion device can include a handlewith releasable locking means for releasably engaging aforementionedflange portion.

If desired or required, the proximal portion of the access port body canbe provided with longitudinal, circumferentially spaced ribs formed onan outer surface of the body, for inhibiting elongation of the proximalend portion of the access port body during the transition from the firstcondition of the bulb portion to the second condition of the bulbportion. Alternatively or additionally, the proximal portion of theaccess port body can be provided with circumferential, longitudinallyspaced ribs formed on an outer surface of the body, for inhibitingcircumferential expansion of the proximal end portion of the access portbody during the transition from the first condition of the bulb portionto the second condition of the bulb portion. Additionally oralternatively, the body can be provided with circumferential,longitudinally spaced ribs formed on an outer surface of the body, forinhibiting removal of the bulb portion from an abdominal wall of apatient.

In accordance with the invention, a seal member can be disposed withinthe lumen, in the proximal end portion of the access port body. Suchseal member can be, for example, a duckbill type valve, ball valve, or afluid seal as set forth, for example in U.S. patent application Ser. No.11/517,929 filed Sep. 8, 2006. Additionally or alternatively, anintegrally formed seal can be provided within the lumen, in the proximalend portion of the access port body. Such seal can be, for example, aprotrusion provided on the wall of the lumen, to seal a space betweenthe wall of the lumen and a surgical instrument. Alternatively oradditionally, sealing can be accomplished by way of a collapsible regiondefined in the proximal end portion of the body such that thecollapsible region can be collapsed by an outside force, to seal thelumen. Such outside force can be, for example, force exerted by theabdominal wall of a patient.

The body can be provided with a first engagement means in the distal endportion thereof, such that a distal end portion of a trocar can engagethe first engagement means. Such engagement means can be tabs, which areconfigured and arranged to be grasped by the trocar, or alternatively, asubstantially rigid stepped element, for engaging a mating portion ofthe trocar. If desired, the body can be provided with second engagementmeans in the proximal end portion thereof, with a proximal end of thetrocar, obturator or other insertion device being adapted for engagingthe second engagement means.

In the foregoing embodiments, the trocar or insertion device preferablyhas a length greater than the first length of the bulb portion of thebody, and therefore causes extension of the bulb portion to the secondlength. If a second engagement means is arranged in the proximal endportion of the body, for engagement with a proximal end portion of thetrocar or insertion device, the insertion device can maintain the accessport body in the second condition while engaged therewith.

In accordance with another preferred embodiment of the subjectinvention, there is provided a surgical access device that includes,among other things, a telescoping guide tube assembly disposed withinthe central lumen of the access port body for accommodating theelongated insertion device. The guide tube assembly is adapted andconfigured to transition between a first length corresponding to thefirst condition of the bulb portion and a second length corresponding tothe second condition of the bulb portion. In addition, the insertiondevice is configured to extend through the guide tube assembly andreleasably engage the guide tube assembly to facilitate the transitionof the access device from the first condition of the bulb portion to thesecond condition of the bulb portion.

Preferably, the telescoping guide tube assembly includes a proximal tubesection and a distal tube section. The proximal tube section is fixedrelative to the access port body and the distal tube section is adaptedto translate relative to the proximal tube section. The distal tubesection of the guide tube assembly includes a nosepiece that extendsfrom the distal end portion of the access port body and has a taperedouter surface. Preferably, the tapered outer surface of the nosepiecemerges into the bulb portion of the access port body, to provide asmooth transition between the two structures. The guide tube assemblyhas an interior engagement ring therein for mating with an exteriorengagement ring provided on the insertion device.

The access port body also includes a plurality of axially spaced apartannular retaining ribs. The plurality of axially spaced apart annularretaining ribs includes two different rib structures. These include afirst rib structure having a horizontal ledge and an angularly inclinedriser and a second rib structure having a generally V-shapedcross-section.

In addition, the access port includes a proximal housing portion thatincludes an inlet opening communicating with the guide tube assembly.The housing portion has an interior chamber that houses a seal memberdesigned to interact with the insertion device or a surgical deviceinserted through the access port. The seal member preferably includes aduckbill seal portion and an annular wiper seal portion.

The insertion device used to facilitate the transition of the bulbportion between the first and second conditions includes a proximalhandle assembly and an elongated trocar shaft that extends distally fromthe handle assembly. The handle assembly preferably includes means forengaging the proximal housing portion of the access port. In thisregard, the proximal housing portion of the access port includes aproximal engagement flange and the handle assembly of the insertiondevice includes a pair of opposed pivoting latching arms for releasablyengaging the flange of the access port.

Preferably, the pivoting locking arms of the handle assembly arenormally biased into a latching position by spring arms or the likedisposed within the handle assembly. The insertion device preferably hasa tissue-penetrating tip at the distal end of the trocar shaft. Thetissue-penetrating tip preferably includes at least two cutting surfacesor facets, and more preferably, the facets define optical lens areas forvisualization during the tissue penetration procedure.

In addition, the handle assembly includes means for receiving alaparoscope that would communicate with the optical lens areas of thetrocar tip. In this regard, the handle assembly includes means forsecuring the position of a laparoscope relative to the insertion device.Preferably, the means for securing the position of the laparoscoperelative to the insertion device includes a rotatable cam lock thatinteracts with a silicone washer designed to compressively engage anouter periphery of the laparoscope. These and other unique features ofthe access device and the insertion device will become more readilyapparent from the following detailed description of the preferredembodiments of the invention taken in conjunction with the associatedfigures.

In accordance with still another aspect of the invention, a method offorming an access port in a patient is provided. The method includes thesteps of providing an access port in accordance with the invention, asset forth herein; providing an insertion device configured to engage thedistal end portion of the access port body; extending the insertiondevice into the central lumen of the access port body so as to engagethe distal end portion of the access port body; elongating the accessport with the insertion device, the end of the insertion device beingengaged with the distal end portion of the access port body; insertingthe access port and insertion device through an abdominal wall of apatient to a predetermined position, while maintaining the access portin an elongated configuration; and removing the insertion device fromthe access port, allowing the access port to revert to the firstconfiguration, with the bulb portion of the access port engaging aninterior surface of the abdominal wall.

The method can further include the step of performing surgery byinserting a surgical instrument through the lumen of the access port,and through an optional rigid member associated with a portion of thebody. The method can further include sealing the central lumen, eitherupon itself, or between the access port and a surgical instrument. Suchsealing can occur by radially inwardly directed force acting on theaccess port, exerted by the abdominal wall of the patient.

Additionally or alternatively, the step of elongating the access portwith the insertion device can further include engaging the insertiondevice with a first engagement means at the distal end of the accessport and elongating the port along the insertion device. Additionally oralternatively, the method can further include the step of engaging asecond engaging means associated with the proximal end of the accessport with a corresponding engagement means on the insertion device toselectively maintain the access port body in an elongated configuration.

In accordance with the invention, the step of inserting the port caninclude inserting the access port through the abdominal wall with theinsertion device in engagement with the first and second engagementmeans of the access port. The methods set forth herein can furtherinclude removing the access port from the abdominal wall. Such removalcan include reengaging the insertion device with the first and secondengagement means to elongate the access port body, and withdrawing theelongated access port from the abdominal wall.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the invention claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the devices and methods of the invention. Together withthe description, the drawings serve to explain the principles of theinvention, wherein:

FIG. 1 is an isometric view of a first representative embodiment of asurgical access device in accordance with the present invention,including an insertion device and an access port;

FIG. 2 is an isometric view of the access port of FIG. 1;

FIG. 3 is a partial cross-sectional view of the surgical access deviceof FIG. 1, showing the insertion device advancing through the accessport;

FIG. 4 is a detail view of region 4 in FIG. 3;

FIG. 5 is a partial cross-sectional view of the surgical access deviceof FIG. 1, showing the insertion effecting extension of the through theaccess port, the figure also illustrating an initial insertion beingmade through an abdominal wall by the insertion device;

FIG. 6 is a detail cross-sectional view of the initial insertion of thesurgical access device, the figure also illustrating the engagementbetween the insertion device and access port at the distal end of thesurgical access device;

FIG. 7 is a partial cross sectional view illustrating the surgicalaccess device of FIG. 1, inserted through the abdominal wall, with theinsertion device partially withdrawn from the access port;

FIG. 8 is a partial cross sectional view illustrating the surgicalaccess device of FIG. 1, inserted through the abdominal wall, with theinsertion almost fully withdrawn from the access port;

FIG. 9 is a cutaway view the access port of the surgical access deviceof the preceding figures, illustrating the access port in use, with asurgical instrument inserted therethrough;

FIG. 10 is an isometric view of another embodiment of an access port ofa surgical access device in accordance with the invention, havinglongitudinal ribs on a neck portion thereof;

FIG. 11 is a partial cross-sectional view of the access port of FIG. 10,taken along line 11-11 of FIG. 10;

FIG. 12 is a cross-sectional view of the access port of the access portof FIG. 10, taken along line 12-12 of FIG. 10;

FIG. 13 is a cutaway view of the access port of FIG. 10, shown in anelongated configuration, with an insertion device inserted therein;

FIG. 14 is a cutaway view of a further embodiment of an access port inaccordance with the invention, having inwardly projecting guide fingersfor facilitating insertion of surgical instruments through the accessport;

FIG. 15 is a partial cross-sectional view of the access port of FIG. 14;

FIG. 16 is a cutaway view of the access port of FIG. 14, shown in anelongated configuration, with an insertion device inserted therein;

FIG. 17 is a cutaway view of a further embodiment of an access port inaccordance with the invention, having a valve and a central guide tubefor facilitating insertion of surgical instruments through the accessport;

FIG. 18 is a partial cross-sectional view taken along line 18-18 of theaccess port of FIG. 17;

FIG. 19 is a partial cross-sectional view taken along line 18-18 of theaccess port of FIG. 17, shown in an elongated configuration, having aninsertion device inserted therein;

FIG. 20 is a cutaway view of still another embodiment of an access portin accordance with the invention, including a reinforcing backstop forengagement with an insertion device in accordance with the invention;

FIG. 21 is a partial cross-sectional view of the access port of FIG. 20,taken along line 21-21;

FIG. 22 is an isometric view of a surgical access device in accordancewith the invention, including the access port of FIG. 20, and aninsertion device having a latching mechanism for engaging the accessport;

FIG. 23 is an isometric view illustrating the surgical access device ofFIG. 22, showing the access port in an elongated configuration inengagement with an insertion device, prepared for insertion through theabdominal wall of a patient;

FIG. 24 is an isometric view of a further embodiment of an access portin accordance with the invention, having a relatively longer neckportion than foregoing embodiments;

FIG. 25 is an isometric view of an additional embodiment of an accessport in accordance with the invention, having a tip with flexible anchorelements provided thereon, for securing the tip to the access port body,and optionally for guiding surgical instruments through the lumen of theaccess port;

FIG. 26 is an isometric view of still another embodiment of an accessport in accordance with the invention, having a flange reinforcingelement provided thereon;

FIG. 27 is an isometric view of another embodiment of an access port inaccordance with the invention, having a guide tube, valve and flangereinforcing element;

FIG. 28 is an exploded view of the access port of FIG. 27;

FIG. 29 is a cross-sectional view taken along line 29-29 of the accessport of FIG. 27, shown in a non-elongated configuration;

FIG. 30 is a detail view of region 30 in FIG. 29;

FIG. 31 is a detail view of region 31 in FIG. 29;

FIG. 32 is a cross-sectional view of the access port of FIG. 27, shownin an elongated configuration with an insertion device inserted in theaccess port;

FIG. 33 is an isometric view of a further embodiment of an access portin accordance with the invention, having a generally flaredconfiguration in the distal end portion thereof and circumferential ribsarranged thereon;

FIG. 34 is a partial cross-sectional view of the access port of FIG. 33;

FIG. 35 is a partial cross-sectional view of the access port of FIG. 33,shown in an elongated configuration with an insertion device inserted inthe access port;

FIG. 36 is an isometric view of yet another access port in accordancewith the invention, having a generally flared configuration in thedistal end portion thereof with longitudinal ribs extending the lengthof the body thereof;

FIG. 37 is a partial cross-sectional view of the access port of FIG. 36;

FIG. 38 is a partial cross-sectional view of the access port of FIG. 36,shown in an elongated configuration with an insertion device inserted inthe access port;

FIG. 39 is an isometric view of still another access port in accordancewith the invention, having longitudinal ribs in a neck portion andcircumferential ribs in the distal end portion thereof;

FIG. 40 is a partial cross-sectional view of the access port of FIG. 39;

FIG. 41 is a partial cross-sectional view of the access port of FIG. 39,shown in an elongated configuration with an insertion device inserted inthe access port;

FIG. 42 an isometric view of a further embodiment of access port inaccordance with the invention, which access port has an enlarged,generally barb-shaped region and a plurality of barb-shaped ribs toinhibit pullout of the access port from the abdominal wall of a patient;

FIG. 43 is an exploded view of the access port of FIG. 42, illustratingthe various components thereof;

FIG. 44 is a side view of the access port of FIG. 42, illustrating inhidden line the arrangement of internal components thereof;

FIG. 45 is a front view of the access port of FIG. 42, also illustratingin hidden line the arrangement of internal components thereof;

FIG. 46 is a perspective view of another embodiment of the elastomericsurgical access device of the subject invention, shown in a relaxed orunstretched condition in which the anchoring bulb has a first diameterand a first length;

FIG. 47 is a perspective view of the elastomeric surgical access deviceof FIG. 46, shown in an elongated or stretched condition in which theanchoring bulb has a second diameter less than the first diameter and asecond length greater than the first length;

FIG. 48 is a cross-sectional view of the elastomeric surgical accessdevice of the subject invention taken along line 48-48 of FIG. 46;

FIG. 49 is a cross-sectional view of the elastomeric surgical accessdevice of the subject invention taken along line 49-49 of FIG. 47;

FIG. 50 is a perspective view of an insert device designed to deploy theelastomeric surgical access device of FIG. 46, which includes a handleassembly and a longitudinally extending trocar having a tissue-piercingtip;

FIG. 51 is cross-sectional view of the insert device of the subjectinvention taken along line 51-51 of FIG. 50;

FIG. 52 is a perspective view of the insert device of FIG. 50 togetherwith the surgical access device of FIG. 46 in an unstretched condition;

FIG. 53 is cross-sectional view taken along line 53-53 of FIG. 52showing the insert device of FIG. 50 together with the surgical accessdevice of FIG. 46 in an unstretched condition;

FIG. 54 is a perspective view of the insert device of FIG. 50 togetherwith the surgical access device of FIG. 46 in an elongated stretchedcondition; and

FIG. 55 is cross-sectional view taken along line 55-55 of FIG. 54showing the insert device of FIG. 50 together with the surgical accessdevice of FIG. 46 in an elongated stretched condition.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference will now be made in detail to the selected embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. The devices and methods presented herein relate to providing asurgical access port to allow insertion and removal of surgicalinstruments during a procedure. The present invention is particularlysuited for use in minimally-invasive surgical procedures of the abdomen,and is suitable for procedures where the abdominal cavity is pressurizedwith insufflation gas.

For purpose of explanation and illustration, and not limitation, anisometric view of an exemplary embodiment of a surgical access device inaccordance with the invention is shown in FIG. 1 and is designatedgenerally by reference character 100. Other embodiments of surgicalaccess devices in accordance with the invention, or aspects thereof, areprovided in FIGS. 2-34, as will be described.

FIGS. 1-9 illustrate the surgical access device 100, and componentsthereof alone, and in conjunction with an abdominal wall (i.e., 530 ofFIGS. 5-9) of a patient, additionally illustrating the steps ofinsertion and use the surgical access device 100. The surgical accessdevice 100 includes, generally, an access port 110 and an inserter 120.The access port is at least partially flexible in its construction, anddepending on the particular embodiment can be primarily composed of oneor more flexible materials. The access port includes a body 118, with aproximal flange 101 and distal tip 107 arranged thereon, at opposed endsthereof. The body 118 includes bulb portion 105 and a neck portion 103,each of which defines a respective portion of a lumen 106 passingtherethrough. Upon insertion, as will be understood, the bulb portion105 assists in anchoring the access port 110 into the abdominal wall 530(e.g., in FIG. 8) of the patient, while the neck portion 103 maintains apassageway through the abdominal wall 530.

The insertion device 120 includes a handle 121 for gripping by a user, ashaft 123, and a distal tip 125. The tip 125 can include an engagementfeature, such as the stepped portion illustrated, which engages a matingstepped interior of the distal tip 107 of the access port 110. Theinsertion device can include a cutting tip at its distal end, or canhave a blunt tip at the end thereof. The insertion device 120,therefore, can be a trocar, a blunt-tip obturator, or a visualizationdevice (e.g., an obturator with a visualization tip and a channel toreceive an endoscope), for example. The flange 101, serves multiplepurposes. Firstly, the flange 101 serves as a location for a user togrip when preparing the access port 110 for insertion. Secondly, theflange 101 acts as a stop to abut the outer surface (skin) of thepatient's abdominal wall, preventing the entire access port 110 frompassing through the incision made to insert the access port. Further,the flange 101 can be provided with a lead in surface 102, which helpsguide the insertion device 120, or other instruments therein andtherethrough.

The tip 107 is provided at the distal end of the body 118 of the accessport 110. The tip 107 is insert molded, adhered, or otherwise secured tothe body 118, details of which are set forth below in connection withother embodiments. Since the tip 107 must securely engage the insertiondevice 120, the tip 107 is preferably made of a relatively rigidmaterial. However, although illustrated as extending distally from thebody 118, the tip can be provided within the body 118, near the distalend thereof, if desired. As such, the tip 107 can be concealed fromview, while still having the necessary rigidity to withstand forcesexerted by the insertion device 120, for example. Variations of the bulbportion 105, neck portion 103, tip 107 and flange 101 are describedbelow in connection with other embodiments. Naturally, these specificfeatures can be interchanged and combined as needed or desired.

FIG. 4 is a detail view of the respective region of FIG. 3. As can beseen, the lead in surface 102 can facilitate insertion of a surgicalinstrument. Additionally, an integral O-ring seal 104 is provided, whichseals between an instrument shaft (illustrated as insertion device shaft123), and the access port 110. Thus, egress of insufflation gas isinhibited. Naturally, such feature can be applied to any embodiment setforth herein. Additionally, the precise configuration of the seal 104can vary, if desired, but the seal 104 can, as illustrated, be a simpleprojection of the seal 104 from the neck portion 103 of the access port110. Moreover, a plurality of seals, such as seal 104 can be provided inseries to further enhance sealing capability.

As shown in FIGS. 5 and 6, in use, the insertion device 120 is insertedthrough the lumen 106 of the access port 110, with the tip 125 of theinsertion device 120, passing through and engaging the tip 107,preventing proximal movement of the tip 107, relative to the insertiondevice 120 (FIG. 6). Next, the flange 101 is pulled proximally by theuser, toward the handle 121 of the insertion device 120, longitudinallyelongating the access port 110, reducing its cross-sectional profile, tofacilitate insertion (e.g., in FIG. 5). The access port 110 ismaintained in an elongated configuration during insertion, as thesurgical access device passes through the abdominal wall 530 of thepatient. Because the access port 110 includes a flexible material, theaccess port 110 can be additionally radially compressed by the abdominalwall during insertion.

The surgical access device 100 is urged through the abdominal wall 530of the patient until the flange 100 meets the surface 531, or skin ofthe abdominal wall 530. FIG. 7 illustrates the surgical access device100 in such a position, with the insertion device 120 slightly withdrawnfrom the access port 110. As the insertion device is withdrawn, the bulbportion 105, now held within the abdominal cavity 535, reverts towardits original configuration, expanding in diameter. The bulb portion 105,therefore, engages the inside surface 532 of the abdominal wall 530. Ifthe access port 110 is configured in such a way that the neck 103elongates during insertion, upon release of tension in the access portapplied by the insertion device 120, the neck 103 attempts to contract,thereby pulling the bulb portion 105 toward the flange 101, helpingsecure the access port 110 to the abdominal wall 530. If provided,however, ribs (e.g., ribs 1004 shown in FIG. 10) can inhibit theelongation of the neck 103, allowing the force exerted in longitudinallyelongating the access port 110 to be focused on reducing the crosssectional profile of the bulb portion 105. Advantageously, as the bulbreverts to its original configuration with the bulb expanded indiameter, the surgical access port foreshortens, the benefits of whichwill be described below.

FIG. 9 illustrates the access port 100 of FIGS. 1-8, with a surgicalinstrument 930 inserted therethrough. As illustrated, the flange 101maintains engagement with the upper and lower surfaces 531, 532 of theabdominal wall 530, even when the access port 110 is manipulated toangle an instrument. Because the surgical access port foreshortensduring insertion and is firmly held in place relative to the abdominalwall by the bulb portion 105 and flange 101, the length of the accessdevice interacting with the surgical instrument is minimized and theforces, which must be exerted to angle and manipulate the surgicalinstrument can therefore be reduced. Further, as can be seen, accessports in accordance with the invention can be sized such that contact ismaintained between the interior neck wall 913 and the shaft 933 of theinstrument 930, thereby maintaining an airtight seal. Additional sealelements, such as one or more internal ribs, can be arrangedcircumferentially on the inner wall 913 of the neck 103, if desired. Ifa plurality of ribs are provided, they can be longitudinally spaced fromone another so as to provide even greater sealing.

In this embodiment, upon withdrawal of the instrument 930, the abdominalwall 530, which continually exerts an inward force on the access port110, causes the lumen 106 in the region of the neck 103 to close, thussealing the lumen 106, inhibiting escape of insufflation gas from thesurgical cavity (e.g., a pneumoperitoneum). Such behavior can be seen,for example, in FIG. 8, illustrating withdrawal of the insertion device120 from the access port 110. This occurs if the neck portion 103 isconfigured so as to allow this to happen. For example, the materialselection must be such that the neck region is sufficiently compliant,compressible and/or collapsible to be affected by the force of theabdominal wall 530—that is, not excessively rigid. For this reason, itmay be desirable to not include longitudinal ribs (e.g., ribs 1004 shownin FIG. 10).

In other instances, however, ribs or other stiffening means may bedesirable. As an alternative to ribs, if desired, a material havingdirectional reinforcement can be utilized, such as a fiber-reinforcedpolymer. As such, the access port 110 can be formed so as to havelongitudinal resistance to elongation, for example at the neck 103,while still easily collapsing radially, so as to seal between the accessport and a surgical instrument.

It should be noted, that if the neck 103 of the access port 110 isconfigured so as to be relatively compliant, the neck can adapt todifferent sizes of surgical instruments inserted therethrough—expandingto the appropriate size to accommodate each tool.

FIGS. 10-13 illustrate an alternate embodiment of a surgical accessdevice in accordance with the invention, designated generally byreference number 1000, which access device 1000 includes an insertiondevice 1020 and access port 1010. The access port 1010 is similar to theaccess port 110 of FIGS. 1-9 in many respects. However, in thisembodiment, the bulb portion 1005 is more spherical than that of accessport 110, which itself is somewhat more elongate in shape. Naturally,the precise shape can be tailored as seen appropriate. The morespherical shape of the bulb portion 1005 of the access port 1010 ofFIGS. 10-13 is particularly advantageous in areas where reducedclearance is present, such as, for example, along lateral sides of theabdominal cavity. In the medial portion of the abdominal cavity,particularly if the abdominal cavity is insufflated, more space isavailable than is available in the lateral regions of the abdominalcavity. The shortened shape of the bulb portion 1005, allows placementof the access port 1010, and allows manipulation of the access port 1010and tools inserted therethrough, within the cavity.

Additionally, elongation-prevention ribs 1004 are provided on the neck1003. As evident, particularly from the cross-sectional view of FIG. 12,the increased cross-sectional area of the neck 1003 affords increasedresistance to the applied tension needed to elongate the access port1010 prior to insertion, while not substantially affecting the abilityof the neck 1003 to contract or expand radially. As mentioned brieflyabove, all or a portion of the access port 1010 can be composed of oneor more materials having directional properties. For example, the neck1003 can be provided with reinforcing fibers embedded within thematerial thereof. Such fibers can be as rigid as desired, to impart thedesired properties on the access port.

Alternatively or additionally, the bulb 1005 or flange 1001 cansimilarly include materials having directional properties. If, forexample, the bulb 1005 is reinforced or is otherwise composed ofmaterial(s) having directional properties, when tension is applied tothe access port 1010 the bulb 1005 will simply deform to a point,elongating as a whole, but without the material itself elongating or“stretching.” Thus, it can therefore be understood that elongation or“stretching” of the material itself used for this and other access portsdescribed herein, is not essential to practice of the invention.

FIG. 12 is a cross-sectional view taken across the neck 1003 of theaccess port 101 of FIG. 10. The ribs 1004 of the neck 1003 are evidentthereon, and the tip 1007 can be seen though the lumen 1006 of theaccess port 1010. FIG. 13 illustrates the access port 1010 of FIG. 10 inan elongated configuration. As can be seen, the relatively sphericalshape of the bulb portion 1005 does not yield an access port 1010 thatis incapable of assuming a low-profile shape.

FIGS. 14-16 illustrate a further embodiment of an access port 1410 inaccordance with the invention. The general shape of the access port 1410is similar to that of the access port 1010 of FIGS. 10-13. The accessport 1410 includes a flange 1501 with a lead-in surface 1502, a body1518 having a neck portion 1503 with longitudinal ribs 1504, and a bulbportion 1505. A distal tip 1507 is also provided thereon for engaging aninsertion device.

However, the access port 1410, and more specifically the tip 1507.includes axially inwardly and radially outwardly directed flexiblefingers 1508, which are provided to line the distal end portion of thelumen 1506, defined within the bulb portion 1505. The fingers 1508 serveto guide surgical instruments toward the lumen of the tip 1507, so as tomore easily pass through the access port 1410 and into surgical cavity.While the access port body 1518 (i.e., the bulb 1505 and the neck 1503)may be made of a material that is relatively soft to allow flexure, thefingers 1508 and additionally the tip 1507 itself can be made of arelatively rigid material. Such material preferably also has arelatively low coefficient of friction against materials used insurgical instruments (e.g., metals and plastics), so that theinstruments are easily guided through the lumen and into the surgicalcavity.

The fingers 1508 also serve to reinforce the distal end portion of thebulb portion 1505, if they are embodied such that they are at leastpartially secured to the bulb 1505. Alternatively, they can simply be incontact with the inner surface 1506 of the bulb 1505, resilientlycontacting the surface 1506. In the illustrated embodiment, particularlyas seen in FIG. 15, the fingers 1508 each include a longitudinal,inwardly projecting portion 1519, extending from the tip 1507. Thelongitudinal portion 1519 is connected to a second, angled portion 1517at a resilient hinge 1520, the geometry of which is configured tomaintain the angled portion 1517 of each finger 1508 in abutment withthe interior surface 1506 of the bulb portion 1505, if the fingers 1508are not already secured thereto. The hinge 1520 can be a so-calledliving hinge, defined in the material of the finger 1508 by a reducedthickness region, for example. Alternatively, the fingers 1508 andhinges 1520 can simply be made of material that is flexible enough tobend during elongation of the access port 1410.

With reference to FIG. 16, it can be seen that when the access port 1410is elongated to result in a reduced cross-sectional profile prior toinsertion, the fingers 1508 flex in conjunction with the bulb 1505. Therelative dimensions of the fingers 1508 can be selected as desired. Forexample, the fingers can widen toward their distal ends (distal withrespect to the tip 1507), in order to better guide instruments throughthe lumen 1506. When in the elongated state, as shown in FIG. 16, suchwidened fingers can lay adjacently to one another, or can be configuredto overlap one another. As such, the fingers cover an increased area,while the access port 1410 is in a first configuration (FIGS. 14, 15),and still allow the elongated, reduced profile configuration of FIG. 16.

With reference to FIGS. 17-19, a further embodiment of an access port1710 in accordance with the invention is provided. The access port 1710includes a proximal flange 1701, a neck 1703 having longitudinal ribs1704, and a bulb portion 1705 terminating in a distal tip 1707. Thedistal tip 1707 is attached to the bulb 1705 in this embodiment byextensions 1709, which provide a location for the material of the bulb1705 to engage the tip 1707. Such engagement can be effected, forexample, by way of insert molding the tip 1707 with the material of thebody (i.e., the bulb 1705 and neck 1703). In the case of the flange1701, as with other flanges set forth herein in connection with otherembodiments, the flange 1701 can be molded integrally with the neck 1703and bulb 1705 portions.

The access port 1710 of FIGS. 17-19 differs from the forgoingembodiments in that the access port 1710 includes a guide tube 1711 anda valve 1709 provided in the lumen 1706 thereof. The guide tube isprovided with a proximal flange 1819, which rests in a recess formed inthe flange 1701 of the access port 1710. The flange 1819 of the guidetube 1711 maintains the tube 1711 in place, and can be insert molded,adhered or otherwise attached to the access port body. The tube 1711serves as a guide during insertion of surgical instruments, helping leadthe instruments toward the tip 1707, reducing the chances that suchinstruments will veer toward the inner wall 1706 of the bulb 1705, whichmight delay the surgical procedure being performed. The guide tube 1711is also preferably made out of material having a relatively lowcoefficient of friction, with respect to the surgical instruments beinginserted therethrough, in order to further facilitate insertion ofsurgical instruments.

The valve 1709, is shown as a duckbill type valve, but can be of anytype desired. Alternatively or additionally, a ball valve and/or or afluid seal can be utilized, as set forth, for example in U.S. patentapplication Ser. No. 11/517,929 filed Sep. 8, 2006, which isincorporated herein by reference in its entirety. The valve 1709 isarranged within the guide tube 1711 and serves to reduce leakage ofinsufflation gas from the surgical cavity (e.g., a pneumoperitoneum),when instruments are removed from the access port 1710. While certain ofthe foregoing embodiments, such as the access port 110 of FIGS. 1-9,seal upon removal of an instrument due to the compressive forces exertedby the abdominal wall, the guide tube 1711, which is relatively rigid,prevents this embodiment from sealing in that manner. Accordingly, thevalve 1709 is provided to seal when an instrument is removed from theaccess port 1710.

FIGS. 20-23 illustrate a surgical access device, including an accessport 2010 and an insertion device 2220. The access port 2010 is similarin many respects to the foregoing access ports, with the exception of areinforcing backstop 2012 provided on the underside of the flange 2001.The backstop 2012 rigidifies the flange 2001, and provides a securesurface for engagement with locking pawls 2223 a, 2223 b of theinsertion device 2220. The pawls 2223 a, 2223 b are preferablyresiliently biased toward a closed position, where protrusions 2225 atthe distal end thereof engage the backstop 2012, inhibiting removal ofthe insertion device 2220 from the access port 2010. A user candisengage the pawls 2223 a, 2223 b by depressing the release end 2224 ofthe pawls 2223 a, 2223 b, which pivot the protrusions 2225 away from theaccess port 2010 and the backstop 2012.

While the above-described latching mechanism can be incorporated intoany of the embodiments set forth herein, the access port 2010illustrated includes a flange 2001, which holds the backstop 2012, aneck 2003 having longitudinal ribs 2004, a bulb portion 2005, and a tip2007, secured to the bulb portion 2005 with extensions 2008.

In use, the user places the insertion device 2220 through the lumen 2006of the access port 2010, elongating the access port 2010 until the pawls2223 a, 2223 b engage the backstop 2012 (See FIG. 23). The access deviceis then inserted through the abdominal wall of the patient. The userthen depresses the release ends 2224 of the pawls 2223 a, 2223 b, andwithdraws the insertion device 2220 from the access port 2010, allowingthe access port 2010 to revert toward its original configuration (as inFIG. 20, for example). The access port may deviate slightly from itsoriginal configuration when inserted because of the forces acting on theaccess port 2010. However, it is to be understood that the configurationof the access port 2010 prior to elongation is very similar to that ofthe access port 2010 when inserted through the abdominal wall.

FIGS. 24-26 illustrate further embodiments of access ports 2410, 2510and 2610 in accordance with the invention, each of which includes anextended neck portion 2403. The extended neck portion 2403 can beparticularly advantageous when the access ports 2410, 2510 and 2610 areused in a patient having a relatively thick layer of abdominal fat, oran otherwise thick abdominal wall. The access port 2410 of FIG. 24 issubstantially similar to many of the foregoing embodiments, with theexception of the elongated neck portion 2403. A proximal flange 2401 isconnected to the elongated neck 2403, which in-turn includeslongitudinal ribs 2404. The bulb 2405 extends from the neck portion 2403and terminates in the distal tip 2407, which is connected thereto viaextensions 2408.

The access port 2510 of FIG. 25 differs from that of FIG. 24, in theconnection between the tip 2507 and the bulb portion 2505. While theconstruction of the flange 2401, neck portion 2403, and ribs 2404 isidentical to that of the access port 2410 of FIG. 24, the tip 2507includes anchor elements 2508, which extend into and are at leastpartially embedded into the material of the bulb 2505. The anchorelements 2508 include a longitudinal, inwardly oriented spine 2519 andone or more transverse protrusions 2518, which are embedded into thewall of the bulb 2505. The spine 2519, if desired, can be embeddedwithin the bulb 2505, or can be arranged such that it is exposed to thelumen 2406 of the access port to aid passage of surgical instrumentsthrough the access port 2510.

The access port 2610 of FIG. 26 includes a configuration having anidentical bulb 2505, tip 2507 and anchor elements 2508 to those of theembodiment of FIG. 25. Similarly, the neck 2403 is identical to each ofthe embodiments of FIGS. 24 and 25. The access port 2610 of FIG. 26includes a rigid flange reinforcement 2612 arranged at the proximal endof the access port 2610. The flange reinforcement 2612 is provided, andin this case, recessed into the flange 2601 to impart increased rigidityto the flange 2601. While the flange 2601 can be integrally formed,e.g., molded, with the neck 2403 and bulb 2505 without suchreinforcement 2612, such material may be undesirably soft to aloneprovide adequate rigidity for the flange 2601, because the flange 2601must be pulled by a user when preparing the access port 2610 forinsertion.

FIGS. 27-31 illustrate an access port 2710 in accordance with theinvention composed of a plurality of components. As with the access port1710 of FIGS. 17-19, the access port 2710 includes a guide tube 2711, avalve 2709, and a body 2718, which in-turn includes a flange 2701, neck2703, bulb 2705, and terminates in a tip 2707. The valve 2709 resideswithin the guide tube 2711, which in-turn is inserted into the body 2718of the access port 2710. A proximal flange 2713 of the guide tube 2711is received by a recess 2813 defined in the flange 2701 of the accessport body 2718.

The access port 2710 additionally includes a flange reinforcement 2712,having a lead in surface 2702 to help guide insertion of surgicalinstruments. As with the access port 2610 of FIG. 26, the flangereinforcement 2712 imparts additional rigidity to the flange 2701. Theflange reinforcement 2712 can be applied to the proximal surface of theflange 2701, or partially or fully recessed therein, as in the accessport 2610 of FIG. 26. The individual components can be mutually securedby way of any suitable means, including, but not limited to heatwelding, ultrasonic welding, solvent welding, adhesive, cohesive or, ifdesired, mechanical interlocking features. FIG. 31, which is a detailview of the respective portion of FIG. 29, illustrates an intermediatebonding material 3140, which can be an adhesive, for example. In apreferred embodiment, the bonding material 3140 is a material that meltsupon application of heat energy, thereby mutually bonding the componentsof the access port 2710. As best seen in FIG. 30, which is a detail viewof the respective region of FIG. 29, the tip 2707 includes an interiorstep 3009, which engages a mating component on the tip 125 of theinsertion device (e.g., see FIG. 32). As can be seen, FIG. 29illustrates the access port 2710 in a first configuration, prior toinsertion through the abdominal wall, and FIG. 32 illustrates the accessport 2710 in a second configuration, prepared for insertion through theabdominal wall of the patient.

FIG. 33 is an isometric view of a further embodiment of an access port3310 in accordance with the invention, having a generally flaredconfiguration in the distal end portion of the body 3318. The flaredregion constitutes a bulb 3305, in that the expanded diameter of thisregion generally resembles such a configuration, and acts to anchor theaccess port 3310 in the abdominal wall of the patient. The access port3310 includes a proximal flange 3301, with a flange reinforcing element3312 arranged thereon, and a distal tip 3307 connected by the body 3318.Longitudinal ribs 3304 are formed on the neck portion 3303, and includea distal taper 3314 so that the ribs gradually approach the contour ofthe bulb portion 3305, as the diameter of the body 3318 increases towardthe distal end of the access port 3310.

Circumferential ribs 3315 further increase the diameter of the bulbportion 3305, providing additional anchoring capability. While theforegoing embodiments can be made from elastomeric materials ornon-elastomeric materials, this embodiment preferably includes amaterial having a predetermined degree of elasticity, particularlybecause the relative diameter of the bulb portion 3305 to the remainderof the body 3318 of the access port 3310 is not as great as in many ofthe foregoing embodiments. Accordingly, when elongated, the material ofthe access port 3310 will stretch, and while the bulb 3305 decreases inprofile, the ribs 3315, which are part of the bulb 3305, will alsostretch longitudinally, effecting a reduction in their cross-sectionalprofile.

FIG. 34 is a partial cross-sectional view of the access port of FIG. 33and FIG. 35 is a partial cross-sectional view of the access port 3310 ofFIG. 33, shown in an elongated configuration with an insertion device120 inserted in the access port.

FIG. 36 is an isometric view of a further embodiment of an access port3610 in accordance with the invention, also having a generally flaredconfiguration in the distal end portion of the body 3618. The flaredregion constitutes a bulb 3605, which serves to anchor the access port3610 in the abdominal wall of the patient. The access port 3610 includesa proximal flange 3301, with a flange reinforcing element 3312 arrangedthereon, and a distal tip 3607, joined via the body 3618, as with theforegoing embodiment of FIG. 33. Longitudinal ribs 3604 are formed onthe body 3618, which extend along the length thereof. The ribs 3604include an increased height portion 3614 toward the distal end thereof,superimposed at an increased diameter portion of the body 3618. Thisembodiment also preferably includes a material having at least somedegree of elasticity. Accordingly, when elongated, the material of theaccess port 3610 will stretch, with the bulb 3605 and ribs 3604decreasing in profile.

FIG. 37 is a partial cross-sectional view of the access port of FIG. 36and FIG. 38 is a partial cross-sectional view of the access port of FIG.36, shown in an elongated configuration with an insertion device 120inserted in the access port 3610.

FIG. 39 is an isometric view of still another access port 3910constructed in accordance with the invention, having longitudinal ribs3904 in a neck portion 3903 and circumferential ribs 3915 in the distalbulb portion 3905 thereof. A tip 3907 is also provided, which isconnected to the flange 3301 and reinforcing member 3312 by the body3918 of the access port 3910. The ribs 3904 in the neck portion 3903serve the purpose of preventing excessive elongation of the neckportion, when preparing the access port 3910 for insertion. Thecircumferential ribs 3915 in the bulb portion 3905 serve to resistunintended pullout of the access port 3910 from the abdominal wall ofthe patient. Therefore, it should be noted that as used herein, the term“bulb” refers to a region of expanded diameter, but which does notnecessarily resemble a “bulb” shape. Accordingly, when elongated, thematerial of the access port 3910 will stretch, and while the bulb 3905decreases in profile, the ribs 3915, which are part of the bulb portion3905, will also stretch longitudinally, effecting a reduction in theircross-sectional profile, thereby facilitating insertion of the accessport 3910 into the abdominal wall of the patient.

FIG. 40 is a partial cross-sectional view of the access port 3910 ofFIG. 39, and FIG. 41 is a partial cross-sectional view of the accessport 3910 of FIG. 39, shown in an elongated configuration with aninsertion device 120 inserted in the access port.

FIGS. 42-45 illustrate an access port 4210 in accordance with theinvention composed of a plurality of components, similar to the accessport 2710 of FIGS. 27-31. The access port 4210 includes a guide tube4211, a valve 4209, and a body 4218, which in-turn includes a flange4201, neck 4203, bulb 4205, and terminates in a tip 4207. The valve 4209resides within the guide tube 4211, which in-turn resides in the body4218 of the access port 4210. A proximal flange 4213 (FIGS. 43-45) ofthe guide tube 4211 resides in a recess defined in the flange 4201 ofthe access port 4210.

The access port 4210 further includes a flange reinforcement 4212,having a lead in surface 4202 to help guide insertion of surgicalinstruments therethrough. As with other access ports set forth herein,the flange reinforcement 4212 helps impart rigidity to the flange 4201.The flange reinforcement 4212 can be applied to the proximal surface ofthe flange 4201, or partially or fully recessed therein.

In this embodiment, as best seen in the exploded view of FIG. 43, forexample, the proximal flange 4213 of the guide tube 4211 is relativelylarge, and in combination with the enlarged flange reinforcement 4212,secures the valve 4209 to the body 4218 of the access port 4210 byengaging the valve 4209 therebetween.

As also can be seen in FIGS. 42-45, the bulb 4205 includes a singledistal enlarged portion 4216, having an angled, generally barbed shape,and a plurality of ribs 4217 arranged along the length of the body 4218,which also have a generally barbed shape. Such shape, due to the angledcontours thereof, enables relatively easy insertion, while stillresisting pullout of the access port 4210 from the patient's abdominalwall.

As with foregoing embodiments, the individual components of the accessport 4210 can be mutually secured by way of any suitable means,including, but not limited to heat welding, ultrasonic welding, solventwelding, adhesive, cohesive or, if desired, mechanical interlockingelements.

In order to remove an access port in accordance with the invention fromthe body of a patient, one can pull the proximal flange (e.g., flange101 of FIG. 8) away from the abdominal wall. The counteracting forceexerted by the abdominal wall will cause the surgical access port, andparticularly the bulb portion (e.g., bulb 105 of FIG. 8) to elongate forremoval from the body cavity into which it was inserted. Alternatively,in order to remove the port, the insertion device, or a similarblunt-tipped tool for engaging the distal end portion of the accessport, can be inserted into the access port to elongate the access portfor removal. The latter method, however, may be preferred in order tominimize trauma to the abdominal wall of the patient.

Referring now to FIGS. 46 through 49, there is illustrated anotherembodiment of the surgical access device of the subject invention, whichis designated generally by reference numeral 5000. Access device 5000 isfunctionally similar to the previously described access devices in thatit is adapted and configured to transition between a relaxed orunstretched condition shown in FIGS. 46 and 48 and an elongated orstretched condition shown in FIGS. 47 and 49, facilitated by a uniqueinsertion device shown in FIG. 50. The construction of access device5000 differs from the previously described access devices in certainrespects, as described in more detail hereinbelow.

Access device 5000 includes an elongated body portion 5100 and aproximal seal housing 5110. Seal housing 5110 has a funnel shapedopening 5112 for receiving a trocar or surgical device and in interiorcylindrical chamber 5115 for supporting a sealing member 5114 (see FIG.48). As best seen in FIGS. 48-49, seal member 5114 is a one-piece sealassembly that includes a proximal seal section 5114 a in the form of awiper seal and a distal valve seal section 5114 b in the form of aduckbill seal. The duckbill seal may be a single plane valve as shown ora double plane valve having two intersecting duckbills.

The seal housing 5110 of access device 5000 also includes a tubularinsufflation port 5116 for mating with a source of pressurized fluid byway of a leur lock fitting or a similar type of connective arrangementknown in the medical arts. The insufflation port 5116 of proximal sealhousing 5110 includes a removable cap 5118 that is connected to the sealhousing 5110 by a living hinge 5125 so that the cap 5118 does not becomedisplaced during a surgical procedure and can be easily reused.

The body portion 5100 of access device 5000 includes an axiallyextendable elastomeric sheath 5120 defining a pathway for permittingminimally invasive access to the abdominal cavity of a patient by asurgical device. The elastomeric sheath 5120 has a generally radiallyoutwardly tapering cross-sectional configuration, in its unstretchedcondition, shown in FIG. 48. The proximal end portion of the sheath 5120has a flange section 5122 of increased thickness (relative to the bodyportion of the sheath) that is secured to the proximal housing 5110 byan underplate 5124. A radially enlarged anchoring bulb 5128 is formedadjacent the distal end of sheath 5120 for securing the access device5000 against the interior wall of the abdominal cavity, once it has beendeployed.

The elastomeric sheath 5120 of access device 5000 includes a pluralityof axially spaced apart annular retaining ribs 5130. More particularly,the sheath 5120 includes two types of alternating ribs 5130, including afirst type 5132 that has a horizontal ledge 5132 a and an angularlyinclined riser 5132 b and a second type 5134 that has a generallyV-shaped cross-section. The ledged ribs 5132 prevent movement of thesheath 5120 in a proximal direction during use, as does the V-shapedribs 5134, although to a lesser extent. The V-shaped ribs 5134 differfrom the ledged ribs 5132 in that they have the same wall thickness asthe sheath 5120 itself, and thus more easily flatten out when the sheath5120 is stretched during deployment, thereby reducing insertionresistance, as best seen in FIG. 48.

Access device 5000 further includes telescoping guide tubes that includean inner tube 5136 and an outer tube 5138. Together, the telescopingguide tubes 5136, 5138 define a passage for a trocar during deploymentof the access device 5000 and a pathway for the introduction of surgicalinstruments. The proximal end of the outer tube 5138 is preferablyintegrally formed with the proximal housing portion 5110 of accessdevice 5000. However, it is envisioned that the outer guide tube 5138could be separate from and secured to the housing portion 5110. Thedistal end of the inner tube 5136 extends from the distal end of sheath5120 and defines a tapered nosepiece 5140 for the access device 5000.The nosepiece 5140 provides a smooth transition surface to the radiallyenlarged anchoring bulb 5128.

As discussed above and throughout this specification, an insertiondevice is utilized to effectuate the transition of the access device5000 between the unstretched and stretched conditions shown in FIGS. 52and 54, respectively. An embodiment of the insertion device of thesubject invention is illustrated in FIGS. 50 and 51, and is designatedgenerally by reference numeral 6000. Together, the insertion device 6000and the access device 5000 form a cooperative system for gaining readyaccess to the abdominal cavity of a patient in order to perform alaparoscopic surgical procedure.

Insertion device 6000 includes a proximal handle assembly 6100 thatincludes a barrel section 6112 and depending ergonomically shaped gripsection 6114. An elongated trocar shaft 6116 extends distally from thebarrel section 6112 of handle assembly 6100. The distal tip 6118 oftrocar shaft 6116 is preferably adapted and configured to pierce throughtissue, including the abdominal wall, and thus includes at least twocutting facets 6118 a, 6118 b.

It is also envisioned and well within the scope of the subjectdisclosure, that trocar shaft 6116 can be configured as an opticaltrocar assembly for purposes of visualizing the penetration into theabdominal cavity. Thus, the distal tissue-piercing tip 6118 of trocarshaft 6116 may include at least two optical facets or viewing windows6118 a, 6118 b that communicate with light transmitting structureswithin the trocar shaft (not shown). Trocar shaft 6116 also includes amedial engagement collar 6120 having circumferentially spaced apartfingers 6122 for interfingering or otherwise meshing with acomplementary spaced apart fingers 5152 of a collar 5150 provided at theproximal end of the inner guide tube 5136 of access device 5000, as bestseen in FIG. 55.

It is envisioned that the engagement collar 6120 on trocar shaft 6116could be alternatively located at the distal end of the shaft, adjacentthe cutting tip 6118, and the complementary collar 5150 could be locatedat the distal end of the inner guide tube 5136. The cooperativeengagement of collars 5150 and 6120 effectively prevents relative radialmovement of the trocar shaft 6115 and body portion 5120, caused by thetorque transmitting by handle assembly 6100 during use.

Referring now to FIG. 51, the proximal end of the trocar shaft 6116 hasa flared end section 6124 that serves to axially secure the trocar shaft6116 within the barrel section 6112 of housing assembly 6100. Handleassembly 6100 further includes a pair of latching arms 6126 and 6128 forreleasably engaging a flange 5170 formed at the proximal end of accessdevice housing 5110, as best seen in FIGS. 52 and 53. The latching arms6126, 6128 pivot about respective pivot pins 6136, 6238 and haverespective inwardly facing engagement fingers 6126 a, 6128 a andrespective integral biasing legs 6126 b, 6128 b that urge the latchingarms 6126 and 6128 into a latching position. The latching arms 6126,6128 are released from the latching position by depressing the opposingintegrally formed buttons 6126 c, 6128 c, which cause the latching arms6126, 6128 to pivot away from one another.

Referring to FIGS. 51 and 53, the handle assembly 6100 of insertiondevice 6000 is adapted and configured to receive a laparoscope (notshown) used to communicate with the optical piercing tip 6118 of trocarhaft 6116. More particularly, the proximal end of barrel section 6112has a reception port 6130 for receiving a laparoscope.

In addition, the handle assembly 6100 of insertion device 6000 includesa mechanism for securing the position of a laparoscope relative to thehandle assembly 6100 of the insertion device 6000. This mechanismincludes a rotatable barrel cam 6132 having a cam slot 6134 thatinteracts with a corresponding cam follower (not shown). The barrel cam6132 is rotated by way of a toggle switch 6136, which causes acorresponding axial translation of the barrel 6132. When the barrel cam6132 moves in a distal direction, it axially compresses an alignedsilicone washer 6135 against an aligned hard plastic retaining washer6138. The silicone washer 6135 is restricted from expanding radiallyoutwardly by the walls of the housing assembly 6100. Consequently, uponbecoming axially compressed against hard plastic washer 6138, thepliable silicone washer 6135 will compress radially inwardly against theouter surface of the tubular laparoscope extending there through. As aresult, the laparoscope is maintained is a fixed position with respectto the barrel section 6112 of handle assembly 6100.

In use, trocar tip 6118 and shaft 6116 are inserted into the proximalopening of access device 5000, as illustrated in FIG. 52. As the trocarshaft 6116 is inserted, the fingers 6122 on collar 6120 (see FIG. 50)engage corresponding fingers 5152 of collar 5150, at the proximal end ofinner guide tube 5136 (see FIG. 48). Engagement of fingers 6122 and 5152orients the inner guide tube 5136 and trocar shaft 6116 in a key andslot style. Housing 5110 is then drawn toward handle assembly 6100 toelongate and stretch elongate body portion 5100, until the latching arms6126, 6128 engage flange 5170 to releasably lock the access device inthe elongated configuration shown in FIGS. 49, 54 and 55).

The length of the trocar shaft 6116 from collar 6120 to penetration tip6118 is selected so that the penetrating tip extends out of the innerguide tube to protrude from the end of the elongated body portion withthe elongated body portion in the stretched position shown in FIGS. 54and 55. Advantageously, because the fingers 6122 and 5152 at a locationproximal to the trocar tip 6118 permits the trocar tip and the nosepiece5140 to be configured to have a low profile and a very smooth gradualtransition from trocar tip 6118 to the elongated body 5100 acrossnosepiece 5140. Engagement of fingers 6122 and 5152 also acts to extendthe inner and outer guide tubes 5136, 5138 within the elongated bodyportion 5100.

With the elongated body portion 5100 mounted to the trocar 6116 as shownin FIG. 54, the access device 5000 is ready for use. The device 5000 maybe inserted through the abdominal wall until the trocar tip 6118 entersthe abdomen. If desired, an optical device such as an endoscope may beoptionally inserted through a central bore of the trocar shaft 6116 topermit visualization through the optical window portions of the trocartip 6118, to observe insertion of the trocar through the abdominal wallinto the abdomen. With the trocar tip 6118 positioned inside theabdomen, the latching arms 6126, 6128 are released from flange 5170,which permits elongated body portion 5120 to resiliently return towardits initial unstretched configuration.

The elongated body portion 5120 may or may not return all the way to theoriginal unstretched position, depending upon the thickness and grippingforce of the surrounding tissue. However, the elongated body portion5120 will return sufficiently toward the initial unstretchedconfiguration so that the bulb portion 5128 expands radially outward tohelp secure or otherwise anchor the access device 5000 within theincision for surgery. The ribs 5130 variously disposed along the bodyportion 5120 also resume their rest position, extending radially outwardfrom the body portion 5120 to assist in securing the access device 5000relative to the patient's body.

At such a time, guide tubes 5136, 5138 return toward the nestedconfiguration shown in FIG. 48. In this configuration, the access device5000 presents a desirably low profile relative to the skin, so thatinstruments can be inserted and removed without obstruction fromadjacent access devices. Thus, surgical instruments may be inserted andremoved in the ordinary course of laparoscopic surgery to perform asurgical procedure. Guide tubes 5136, 5138 guide the surgicalinstruments into the body and protect the elastomeric elongated bodyportion 5120 from damage or puncture due to engagement with instrumentshaving aggressively configured tips (such as clip appliers, staplers,etc.).

After surgery is complete, the trocar tip 6118 may be reinserted intothe access device 5000 to elongate and stretch the elongated body 5120for ease of removal from the patient's body. Alternatively, it iscontemplated that the access device 5000 may simply be pulled out of thebody, such as by grabbing and pulling on housing 5110. As the housing ispulled away from the body, elongate body 5120 will partially elongateand stretch against the resistance of the tissue until the bulb portion5128 and ribs 5130 stretch sufficiently to slip out of the tissue and beremoved.

Surgical access devices in accordance with the invention can serve manypurposes, only one of which is use in minimally-invasive surgicalprocedures. It should be appreciated by those skilled in the art, thataccess ports in accordance with the invention can be used whereveraccess, particularly sealable access, into a body cavity is needed.

The specific dimensions of surgical access devices, including accessports, in accordance with the invention can be selected as needed.Specifically, it is envisioned that a wide variety of sizes will beavailable to a user to enable the user to select the most appropriatelydimensioned device for the patient and procedure at hand. The overalllength of access ports in accordance with the invention can vary, aswell as the relative lengths of the neck portions, diameters and lengthsof bulb portions, dimensions of the flange dimensions of the accessport, and the like. It is envisioned that the access ports set forthherein can replace typical rigid cannulas. Accordingly, generaldimensions similar to such typical rigid cannulas are possible, althoughan operative (during surgery) length of the surgical access port, whichis less than that of typical cannulas, is preferable.

Materials for access ports in accordance with the invention can include,as set forth above, plastics, composites, elastomers or metals ifnecessary, for any component or components thereof. For example, theflange and or tip can be reinforced by rigid plastic or metalcomponents. As set forth above, materials having directional propertiesmay be desirable.

The devices and methods of the present invention, as described above andshown in the drawings, provide for a surgical access device withsuperior properties including secure anchoring to the abdominal wall,low manufacture costs, and sealable access to a pneumoperitoneum. Itwill be apparent to those skilled in the art that various modificationsand variations can be made in the device and method of the presentinvention without departing from the spirit or scope of the invention.For example, an insufflation port can be incorporated into the subjectsurgical access port, if desired. Thus, it is intended that the presentinvention include modifications and variations that are within the scopeof the appended claims and their equivalents.

1. A surgical access device comprising: a) an access port having anelongated body with opposed proximal and distal end portions, the bodyhaving a central lumen extending therethrough and having a resilientbulb portion formed between the proximal and distal end portionsthereof, wherein the resilient bulb portion is adapted and configured totransition between a first condition in which the bulb portion has afirst diameter and a first length and a second condition in which thebulb portion has a second diameter that is less than the first diameterand a second length that is greater than the first length; and b) atelescoping guide tube assembly disposed within the central lumen of theaccess port body, wherein the guide tube assembly is adapted andconfigured to transition between a first length corresponding to thefirst condition of the bulb portion and a second length corresponding tothe second condition of the bulb portion, wherein: i) the telescopingguide tube assembly includes proximal and distal tube sections thatcooperate together to define a passage within the central lumen of theaccess port body for an insertion device; ii) each of the proximal anddistal tube sections each has a proximal end and a distal end; iii) theproximal ends and distal ends of the proximal and distal tube sectionsare co-located when the bulb portion is in the first condition; and iv)the proximal end of the distal tube section and the distal end of theproximal tube section are co-located when the bulb portion is in thesecond condition.
 2. A surgical access device as recited in claim 1,further comprising an insertion device adapted to extend into thecentral lumen of the access port body, through the passage defined bythe proximal and distal tube sections of the telescoping guide tubeassembly, and configured to releasably engage the guide tube assembly soas to facilitate the transition of the bulb portion from the firstcondition to the second condition.
 3. A surgical access device asrecited in claim 2, wherein the guide tube assembly has an engagementring therein for mating with a corresponding engagement ring provided onthe insertion device.
 4. A surgical access device as recited in claim 3,wherein a proximal end portion of the distal section of the guide tubeassembly includes the engagement ring.
 5. A surgical access device asrecited in claim 3, wherein an elongated trocar shaft of the insertiondevice includes the corresponding engagement ring.
 6. A surgical accessdevice as recited in claim 5, wherein the corresponding engagement ringis associated with a medial portion of the trocar shaft.
 7. A surgicalaccess device as recited in claim 2, wherein the insertion deviceincludes a handle assembly and an elongated trocar shaft extendingdistally from the handle assembly.
 8. A surgical access device asrecited in claim 7, wherein the access port includes a housing portionassociated with the proximal end portion of the access port body, andthe housing portion includes a proximal engagement flange.
 9. A surgicalaccess device as recited in claim 8, wherein the handle assembly of theinsertion device includes means for releasably engaging the engagementflange of the housing portion.
 10. A surgical access device as recitedin claim 9, wherein the means for releasably engaging the engagementflange of the housing portion includes a pair of opposed pivotinglatching arms for releasably engaging the flange of the access port. 11.A surgical access device as recited in claim 10, wherein the pivotinglatching arms of the handle assembly are normally biased into a latchingposition.
 12. A surgical access device as recited in claim 7, whereinthe trocar shaft has a distal tissue-penetrating tip that includes atleast one optical window.
 13. A surgical access device as recited inclaim 12, wherein the at least one optical window includes at least twofacets, and each of the facets defines an optical lens area.
 14. Asurgical access device as recited in claim 13, wherein the handleassembly includes means for receiving a laparoscope for communicatingwith the optical lens areas of the distal tissue-penetrating tip of theinsertion device.
 15. A surgical access device as recited in claim 14,wherein the handle assembly of the insertion device includes means forsecuring the position of a laparoscope relative to the insertion device.16. A surgical access device as recited in claim 15, wherein the meansfor securing the position of a laparoscope relative to the insertiondevice includes a rotatable barrel cam for compressing an elastomericwasher about an outer periphery of a laparoscope.
 17. A surgical accessdevice as recited in claim 1, wherein the proximal tube section has afixed position relative to the access port body and the distal tubesection is adapted to translate relative to the proximal tube section.18. A surgical access device as recited in claim 17, wherein the distaltube section of the guide tube assembly includes a nosepiece extendingfrom the distal end portion of the access port body and having a taperedouter surface.
 19. A surgical access device as recited in claim 18,wherein the tapered outer surface of the nosepiece merges into the outersurface of the bulb portion of the access port body.
 20. A surgicalaccess device as recited in claim 3, wherein the access port bodyincludes a plurality of axially spaced apart annular retaining ribs. 21.A surgical access device as recited in claim 20, wherein the pluralityof axially spaced apart annular retaining ribs includes two differentrib structures, including a first rib structure having a horizontalledge and an angularly inclined riser and a second rib structure havinga generally V-shaped cross-section.
 22. A surgical access device asrecited in claim 21, wherein the access port body includes alternatingaxially spaced first and second rib structures.
 23. A surgical accessdevice as recited in claim 1, wherein the access port includes a housingportion associated with the proximal end portion of the access portbody, the housing portion containing a seal member for interacting withthe insertion device.
 24. A surgical access device as recited in claim23, wherein the seal member includes a duckbill seal portion and anannular wiper seal portion.
 25. A surgical access device as recited inclaim 23, wherein the proximal housing portion of the access portincludes an insufflation port.
 26. A surgical access device as recitedin claim 25, wherein the insufflation port includes a removable cap. 27.A method of performing surgery comprising: a) providing an access porthaving an elongated body with opposed proximal and distal end portions,the body having a central lumen extending therethrough and having aresilient bulb portion formed between the proximal and distal endportions thereof, wherein the resilient bulb portion is adapted andconfigured to transition between a first condition in which the bulbportion has a first diameter and a first length and a second conditionin which the bulb portion has a second diameter that is less than thefirst diameter and a second length that is greater than the firstlength, and a telescoping guide tube assembly disposed within thecentral lumen of the access port body, wherein the guide tube assemblyincludes proximal and distal tube sections that are adapted andconfigured to transition between a first length corresponding to thefirst condition of the bulb portion and a second length corresponding tothe second condition of the bulb portion, wherein the proximal anddistal tube sections of the guide tube assembly cooperate together todefine a passage for a trocar and wherein: i) each of the proximal anddistal tube sections each has a proximal end and a distal end; ii) theproximal ends and distal ends of the proximal and distal tube sectionsare co-located when the bulb portion is in the first condition; and iii)the proximal end of the distal tube section and the distal end of theproximal tube section are co-located when the bulb portion is in thesecond condition; b) inserting a trocar shaft into the central lumen,through the passage defined by the proximal and distal tube sections ofthe guide tube assembly, to extend the body and transition the bulbportion from the first diameter to the second diameter and to transitionthe guide tube assembly from the first length to the second length andto cause the proximal end of the distal tube section and the distal endof the proximal tube section to be co-located; and c) inserting theaccess device through tissue with the bulb portion in the condition ofthe second diameter and the guide tube assembly in the condition of thesecond length.
 28. A method according to claim 27, further comprisingreleasing the body from the trocar shaft, thereby permitting the bulbportion to return to the first diameter to anchor the access device intissue.